Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

BTI 1980-07-08

PORTA-NEB(R) 310

Applicant E.B.E. Research & Mfg., Inc.

K-Number K801286

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DRT 1980-07-08

ABBY II PATIENT MONITOR OR VITAL SIGNS M

Applicant Abbott Medical Electronics Co.

K-Number K801515

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LCS 1980-07-08

AMERLEX DIGOXIN RIA KIT

Applicant Amersham Corp.

K-Number K801413

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KOC 1980-07-08

BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR

Applicant Cordis Corp.

K-Number K801355

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JJY 1980-07-08

UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE

Applicant Warner-Lambert Co.

K-Number K801335

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FHN 1980-07-08

HEMORRHOIDAL LIGATION INSTR. SYSTEM

Applicant Depuy, Inc.

K-Number K801352

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DAD 1980-07-08

HAPTOGLOBIN NEPHELOMETRIC ASSAY

Applicant J.T. Baker Chemical Co.

K-Number K801433

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CID 1980-06-30

ALIZARIN SULFONATE, CALCIUM

Applicant Union Carbide Corp.

K-Number K801290

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DXY 1980-06-30

UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.

Applicant Arco Medical Products Co.

K-Number K801241

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HHR 1980-06-30

CO2 LASER

Applicant Advanced Biomedical Instruments

K-Number K801197

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DXY 1980-06-30

PROGRAMMABLE BIPOLAR CARDIAC GENERATOR

Applicant Arco Medical Products Co.

K-Number K800837

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EWO 1980-06-30

CLINICAL AUDIOMETER MODEL TA-200

Applicant Teledyne Avionics Div. of Teledyne

K-Number K801325

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